The Power Groshong™ PICC is intended for short or long-term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. The maximum recommended infusion rate is 4 ml/sec for power injection of contrast media.

Device Description

The PowerGroshong™ PICC catheters are valved, long-term peripheral access catheters. The catheters are made of silicone material to which a blue and purple colorant have been added. Blue colorants were added to the catheter materials to allow the users to identify the catheter as a Groshong distally valved catheter. Purple colorants were added to the catheter materials to provide the catheter with an appearance that allows the end user to differentiate Bard's power injectable catheters from other manufacturers' power injectable catheters. The PowerGroshong™ PICC catheters are available in 5 Fr single lumen catheter configuration. The catheters are packaged in basic and full with microintroducer kits that incorporate kit components designed to meet the needs of the respective placer.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device (5 Fr Single Lumen (SL) PowerGroshong™ PICC Catheter) and a determination of its substantial equivalence to predicate devices. It does not contain information about acceptance criteria and a study that proves the device meets those criteria in the typical format of a clinical trial or performance study with detailed metrics like accuracy, sensitivity, specificity, or F1-scores.

Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed devices, which is a different regulatory pathway than proving novel performance. The "acceptance criteria" in this context refer to meeting the relevant standards and guidance documents to show that the new characteristics of the device do not raise new safety or effectiveness questions and that its performance is comparable to the predicates.

Here's a breakdown of the information that is present, interpreted in the context of a 510(k) submission, and where information typically found in an AI/diagnostic study is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category (Type of Test)	Acceptance Criteria (Implied by Standards)	Reported Device Performance (Summary)
Intended Use Equivalence	The intended use and indications for use of the new device should be a combination of or substantially similar to the indications from the predicate devices. The new characteristic (power injection) should be supported by performance data and not introduce new safety concerns.	The intended use of the 5 Fr SL PowerGroshong is stated to be the same as the predicate devices, with the addition of power injection capability. "The PowerGroshong™ PICC is intended for short or long-term peripheral access to the central venous system for intravenous therapy and blood sampling," and "power injection of contrast media. The maximum recommended infusion rate is 4 ml/sec for power injection of contrast media." The submission asserts that the intended use and indications for use are a combination of the predicate Groshong® nXt and PowerPICC® catheters. Performance testing specifically addressed the new characteristic of power injection to ensure safety and effectiveness.
Technological Characteristics	Principles of operation and basic design should be the same as predicate devices, or differences should be justified and shown not to affect safety or effectiveness negatively.	The principles of operation and basic design are stated to be the same as the predicate devices. The main difference is the addition of power injection to a valved catheter. This was identified as potentially affecting safety or effectiveness, thus requiring testing.
Safety and Effectiveness	New characteristics should not raise new types of safety and effectiveness questions. Accepted scientific methods (standards, guidance) must exist to assess effects, and performance data must be available to assess these effects.	The submission states that the new characteristics (power injection) do not raise new types of safety and effectiveness questions, but rather questions that are "the same as for the predicate devices." Bench testing was performed based on applicable standards and an FDA guidance document to assess these new characteristics. The conclusion states, "All test results confirm that the subject device is substantially equivalent to the predicate devices." And subsequently, "The 5 Fr SL PowerGroshong™ PICC met all the performance criteria of the tests performed and, based on FDA's decision tree, is substantially equivalent to its predicate devices."
Compliance with Standards	Device must meet the requirements of specified industry standards and FDA guidance for intravascular catheters (e.g., ISO 10555 series for catheters, ISO 594-2 for Luer fittings, ASTM F640 for radiopacity, ISO 11135 for sterilization, ISO 10993-1 for biocompatibility).	Bench testing was based on the following: * Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95 * BS/EN/ISO 10555-1: 1997, Sterile, single-use intravascular catheters, Part 1. General requirements * ISO 10555-1:1995, Sterile, single-use intravascular catheters, Part 1. General requirements, Amendment 1:1999 * BS/EN/ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3. Central venous catheters * ISO 594-2: 1998. Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings * ASTM F640-79 (reapproved 2000), Standard Test Methods for Radiopacity of Plastics for Medical Use * AAMI/ANSI/ISO 11135:1994, Medical Devices Validation and Routine Control of Ethylene Oxide Sterilization * AAMI/ANSI/ISO 10993-1:2003, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile. The conclusion states all performance criteria of the tests performed were met.

Regarding "AI" and "Study" Specifics:

The provided document is for a traditional medical device (a catheter), not a software-as-a-medical-device (SaMD) or an AI-powered diagnostic tool. Therefore, the concepts of "AI," "test set," "training set," "ground truth experts," "MRMC study," "standalone algorithm," and "data provenance" (in the context of clinical images/data for AI inference) are not applicable to this submission.

Here's why and where those elements would typically appear if it were an AI device:

No AI Component: There is no mention or indication of artificial intelligence, machine learning, or any computational algorithm for analysis or decision-making. This is a physical plastic device.
No Test/Training Sets (in the AI sense): The "testing" involved bench testing of the physical properties and performance of the catheter (e.g., flow rates, material compatibility, strength, radiopacity, sterilization effectiveness), not an evaluation of an algorithm's classification or detection performance on a dataset.
No Experts for Ground Truth: No experts were needed to establish ground truth for an AI model because there is no AI model. The "ground truth" here is adherence to engineering specifications and performance benchmarks derived from industry standards.
No Adjudication Method: Not applicable for a physical device's bench testing.
No MRMC Comparative Effectiveness Study: An MRMC study compares human reader performance (with and without AI assistance). Since there's no AI, this is irrelevant.
No Standalone Algorithm Study: There is no algorithm to study in standalone mode.
Type of Ground Truth: For this device, the "ground truth" is defined by the specifications for the device itself and the requirements outlined in the referenced standards. For example, a catheter either meets a certain radiopacity standard or it doesn't; its luer lock either conforms to ISO 594-2 or it doesn't.
No Training Set Sample Size/Ground Truth: Not applicable. Device components are manufactured to specifications and tested against those specifications, rather than "trained" on data.

In summary, while the document confirms that the device met all performance criteria of the tests performed and was deemed "substantially equivalent" to its predicates based on established scientific methods and standards, this is fundamentally different from the kind of performance validation expected for an AI/ML-driven device.

Summary

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K063848

PowerGroshong Traditional 510(k)

APR - 4 2007

Section 5 5 Fr Single Lumen (SL) PowerGroshong™ PICC Catheter 510(k) Summary

5.1 General Information

Submitter Name:	Bard Access Systems, Inc. (BAS)
	[Wholly owned Subsidiary of C. R. Bard, Inc.]
Address:	5425 W. Amelia Earhart Drive
	Salt Lake City, UT 84116
Telephone Number:	(801) 595-0700 ext. 7136
Fax Number:	(801) 595-5425
Contact Person:	Lynn M. Kirchoff
Date of Preparation:	December 27, 2006
Registration Number:	1720496
Additional Registration Numbers:
C.R. Bard:	2212754

5.2 Subject Device Information

Device Name:	5 Fr Single Lumen (SL) PowerGroshong™ PICC Catheter
Trade Name:	5 Fr Single Lumen (SL) PowerGroshong™ PICC Catheter
Common/Usual Name:	Peripherally Inserted Central Catheter (PICC)
Classification Name:	80 LJS - Percutaneous, Implanted, Long-Term Intravascular Catheter21 CFR 880.5970- Class II
Classification Panel:	General Hospital

5.3 Predicate Device Information

Device Name(s):	5 Fr Dual Lumen (DL) Groshong® nXt PICC Catheter
	6 Fr Triple Lumen (TL) PowerPICC® Catheter
Trade Name(s):	Groshong® nXt, PowerPICC®
Common/Usual Name:	Peripherally Inserted Central Catheter (PICC)
Classification Name:	80 LJS - Percutaneous, Implanted, Long-Term Intravascular Catheter21 CFR 880.5970- Class II
Classification Panel:	General Hospital

Predicate Device Name	510(k)	Clearance Date
5 Fr DL Groshong® nXt PICC Catheter	K023374	12/18/2002
6 Fr TL PowerPICC® Catheter	K053501	1/13/2006

5.4 Intended Use

The intended use of the 5 Fr SL PowerGroshong is the same as the intended use of the predicate devices.

The PowerGroshong™ PICC is intended for short or long-term peripheral access to the central venous system for intravenous therapy, and blood sampling.

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K063848 page 2 of
PowerGroshong™
Traditional 510(k)

Indications for Use ર્સ્ડ

The Indications for Use for the 5 Fr SL PowerGroshong™ PICC Catheter is as follows:

The PowerGroshong™ PICC is intended for short or long-term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. The maximum recommended infusion rate is 4 ml/sec for power injection of contrast media.

Device Description 5.6

5.7 Technological Comparison to Predicate Devices

The technological characteristics of the 5 Fr SL PowerGroshong™ PICC are substantially equivalent to those of the predicate devices in terms of intended use, application, basic design, performance, labeling, packaging and sterilization method.

5.8 510(k) Substantial Equivalence Decision Tree

New device is compared to Marketed Device? Yes.

Does the new device have the same indication statement and intended use as the predicate? Yes. The intended use and indications for use are a combination of the indications from the predicate Groshong® nXt and PowerPICC® catheters 510(k) K023374 and K053501.

Does the new device have the same technological characteristics, e.g. design, materials, etc.? Not in all regards. The principles of operation and basic design are the same as the predicate devices. The main difference is the addition of the power injection to a valved catheter.

Could the new characteristics affect safety or effectiveness?

Yes. The design changes may affect safety or effectiveness of the device.

Do the new characteristics raise new types of safety and effectiveness questions? No. Safety and effectiveness questions are the same as for the predicate devices.

Do accepted scientific methods exist for assessing effects of the new characteristics? Yes. Testing was performed to assess the new characteristics and was based on the following applicable standards and FDA guidance document:

o Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95
BS/EN/ISO 10555-1: 1997, Sterile, single-use intravascular catheters, Part 1. General O requirements

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BS/EN/ISO 10555-1: 1997, Sterile, single-use intravascular catheters, Part 1. General o requirements
ISO 10555-1:1995, Sterile, single-use intravascular catheters, Part 1. General 0 requirements, Amendment 1:1999
BS/EN/ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3. Central 0 venous catheters
ISO 594-2: 1998. Conical fittings with a 6% (Luer) taper for syringes, needles and O certain other medical equipment - Part 2: Lock Fittings
ASTM F640-79 (reapproved 2000), Standard Test Methods for Radiopacity of Plastics O for Medical Use
ี AAMI/ANSI/ISO 11135:1994, Medical Devices Validation and Routine Control of o Ethylene Oxide Sterilization
AAMI/ANSI/ISO 10993-1:2003, Biological Evaluation of Medical Devices Part 1: o Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile

Are performance data available to assess effects of new characteristics?

Yes. Bench testing was based on the above referenced guidance document and standards. All test results confirm that the subject device is substantially equivalent to the predicate devices.

5.9 Conclusion

The 5 Fr SL PowerGroshong™ PICC met all the performance criteria of the tests performed and, based on FDA's decision tree, is substantially equivalent to its predicate devices, the 5 Fr DL Groshong® nXt PICC and the 6 Fr TL PowerPICC® Catheter covered by: K023374 and K053501 respectively.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bard Access Systems, Incorporated Ms. Lynn M. Kirchoff Regulatory Affairs Specialist 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116

APR - 4 2007

Re: K063848

Trade/Device Name: 5 Fr SL PowerGroshong™ PICC Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: March 1, 2007 Received: March 2, 2007

Dear Ms. Kirchoff:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 Indications for Use

510(k) Number (if known): K063848

Device Name: 5 Fr SL PowerGroshong™ PICC Catheter

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cari-OW) trion of Anesthesiology, General Hospital, Chacaon Control, Dental Devices

C(k) Number ....

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”